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Percent Change in Wound Area of Diabetic Foot Ulcers Over a 4-Week Period Is a Robust Predictor of Complete Healing in a 12-Week Prospective Trial

¹ Diabetes Foot and Ankle Center, Hospital for Joint Diseases Orthopaedic Institute, New York University School of Medicine, New York, New York
² With Confidence Ltd., Surrey, U.K.
³ Joslin-Beth Israel Deaconess Foot Center and Microcirculation Laboratory, Department of Surgery, Beth Israel-Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts

OBJECTIVE—To assess the ability of the 4-week healing rate to predict complete healing over a 12-week period in a large prospective multicenter trial of diabetic patients with foot ulceration.

RESEARCH DESIGN AND METHODS—We examined the change in ulcer area over a 4-week period as a predictor of wound healing within 12 weeks in patients who were seen weekly in a prospective, randomized controlled trial.

RESULTS—Wound area measurements at baseline and after 4 weeks were performed in 203 patients. The midpoint between the percentage area reduction from baseline at 4 weeks in patients healed versus those not healed at 12 weeks was found to be 53%. Subjects with a reduction in ulcer area greater than the 4-week median had a 12-week healing rate of 58%, whereas those with reduction in ulcer area less than the 4-week median had a healing rate of only 9% (P < 0.01). The absolute change in ulcer area at 4 weeks was significantly greater in healers versus nonhealers (1.5 vs. 0.8 cm², P < 0.02). The percent change in wound area at 4 weeks in those who healed was 82% (95% CI 70–94), whereas in those who failed to heal, the percent change in wound area was 25% (15–35; P < 0.001).

CONCLUSIONS—The percent change in foot ulcer area after 4 weeks of observation is a robust predictor of healing at 12 weeks. This simple tool may serve as a pivotal clinical decision point in the care of diabetic foot ulcers for early identification of patients who may not respond to standard care and may need additional treatment.

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